Developing medical devices for start-ups: Overcoming regulatory hurdles Overcoming regulatory challenges in medical device development for startups is like trying to find your way through a maze. Complex legislation, lengthy authorization processes and constant regulatory changes require perseverance and expertise.
Tibor Zechmeister, an experienced regulatory expert, co-founder and partner of CommuModo GmbH, joined us at the meeting of Austrian, Styrian and Slovenian stakeholders of the healthcare ecosystem.
Tibor shared his knowledge and extensive experience and emphasized that regulation is the biggest challenge for medtech startups in Europe. Strict approval procedures, high compliance costs and complex regulatory processes make it difficult to bring innovative medical products to market quickly.
In his advice to startups, he highlighted 3 key things to consider when dealing with medical regulation:
1. Never underestimate regulation. Understanding and complying with the law is critical to the success of your business.
2. Prepare an excellent and viable business plan. A clear strategy and objectives will help you successfully overcome regulatory obstacles.
3. Expect the long road to certification, which can take years. Patience and perseverance are key to obtaining the necessary approvals.
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